Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04668378
Other study ID # TRE-RET
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2014
Est. completion date August 31, 2017

Study information

Verified date December 2020
Source University of Padova
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study sought to investigate the effects of 16/8 time restricted eating (TRE) with windows of 16 hours of fasting and 8 hours of eating on on body composition, muscle strength, and metabolic factors during resistance training in healthy resistance trained males


Description:

Thirty-four resistance-trained males were randomly assigned to a TRE group or to a control normal pattern group (ND) with a traditional meal pattern. The TRE group consumed 100% of the daily energy needs in an 8-hour time window: from 1PM (post meridiem) to 8:00 PM whilst the ND group consumed 100% of their daily energy needs in 3 meals between 8:00 AM (ante meridiem) and 8:00 PM. During the experimental period, training loads were similar and standardize in the two groups. partecipants were tested before and after 8 weeks of the intervention. Body composition , basal metabolism, performances indexes and blood parameters were measured. After the completition of the first two months of study, subjects were ask to volunteer to continue the intervention for 10 extra months. A total of twenty subjects from, 10 from each group (TRE or ND) continued and completed the second part of the study.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date August 31, 2017
Est. primary completion date March 31, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 20 Years to 40 Years
Eligibility Inclusion Criteria: - continuously engaged in resistance training for at least 5 years - at least 3 years experience in split training routines - male Exclusion Criteria: - adherence to special diets - use of nutritional supplements (except a daily multivitamin-mineral and/or protein supplement) - use of steroids - use of medications

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Time restricted eating
TRE subjects consumed 100 % of their energy needs divided into three meals consumed at 1 p.m., 4 p.m. and 8 p.m., and fasted for the remaining 16 h per 24-h period.
Normal Diet
ND group ingested their caloric intake as three meals consumed at 8 a.m., 1 p.m. and 8 p.m.

Locations

Country Name City State
Italy Nutrition and Exercise Lab, DSB, University of Padova Padova

Sponsors (1)

Lead Sponsor Collaborator
University of Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Fat Mass fat mass measured dual energy X-ray absorptiometry (DXA) change from baseline to up to 2 months
Primary Fat Free Mass fat free mass measured dual energy X-ray absorptiometry (DXA) change from baseline to up to 2 months
Secondary Fat Mass fat mass measured dual energy X-ray absorptiometry (DXA) change from baseline to up to 12 months
Secondary Fat Free Mass fat free mass measured dual energy X-ray absorptiometry (DXA) change from baseline to up to 12 months
Secondary total cholesterol total cholesterol as milligram per deciliter change from baseline to up to 2 months
Secondary total cholesterol total cholesterol as milligram per deciliter change from baseline to up to 12 months
Secondary glucose glucose as milligram per deciliter change from baseline to up to 2 months
Secondary glucose glucose as milligram per deciliter change from baseline to up to 12 months
Secondary Leg muscle strength Leg muscle strength measured via via 1-RM test change from baseline to up to 2 months
Secondary Leg muscle strength Leg muscle strength measured via via 1-RM test change from baseline to up to 12 months
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1